Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status

Consideration of whether a product is subject to veterinary prescription or not is an outcome of product assessment and therefore requires detailed consideration. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC establishes, in Article 34, the legal framework for the classification of veterinary medicinal products. Whilst some of the provisions in Article 34 of Regulation (EU) 2019/6 are relatively clear-cut, some others will benefit from further elaboration. It is the intention of the guideline to provide clear guidance for the practical application of the provisions in Article 34 of Regulation (EU) 2019/6. To ensure a consistent implementation and a harmonised EU approach, the assessment principles for the various provisions of Article 34 of Regulation (EU) 2019/6 are laid out.

Keywords: VMP Regulation implementation, classification of veterinary medicinal products, veterinary prescription, non – Prescription Only Medicine – Veterinary (non-POM-V)